Breast Ptosis, Obesity
Conditions
Keywords
Abdominoplasty, Reduction Mammaplasty, Mastopexy
Brief summary
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
Detailed description
One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin. Surgical sutures continue to be the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence. Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.
Interventions
DEVICEV-Loc 180/90 Wound Closure Device
Barbed absorbable suture
DEVICE3-0 Monocryl Absorbable Sutures
3-0 Monocryl Absorbable Suture (non-barbed)
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 years of age or older. * Subject must be in good overall health. * Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants. * Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.
Exclusion criteria
* Subject is pregnant or breast-feeding. * Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing. * Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side. * Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone. * Subject has a BMI ≥ 40. * Subject has diabetes requiring medication for glycemic control. * Subject has a fever (temperature \> 38ºC), active skin infection or systemic infection at the time of surgery. * Subject underwent chemotherapy or radiation within the last 6 months. * Subject has a history of keloid or hypertrophic scar formation or other dermatologic conditions known to impair wound healing. * Subject has a history of alcohol or drug abuse within 6 months prior to screening. * Subject has a history of immunosuppressive drug use, including steroids, within the last 6 months. * Subject has had a documented breast imaging finding or physical breast exam finding requiring further evaluation prior to elective surgery. * Subject has not had a mammogram within the last 12 months, for female patients ≥ 40 years of age scheduled for mastopexy or reduction mammaplasty. * Subject is taking part in another clinical study which directly relates to this study. If, however, the subject is taking part in a non-related study, the investigator should contact the Study Manager for advice. * The investigator determines that the subject should not be included in the study for reasons not already specified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Dermal Closure Time | At time of surgery | In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis | 12 weeks | Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20). |
Countries
Germany, United States
Participant flow
Recruitment details
First subject was consented 12Aug2009 and last subject final follow up visit 15May2011. 241 subjects were enrolled from 9 sites in the USA and Europe. Of those, 229 were consented, randomized and treated. All subjects were volunteers scheduled for individual or combined abdominoplasty, mastopexy or reduction mammaplasty.
Participants by arm
| Arm | Count |
|---|---|
| V-loc and Monocryl All randomized subjects | 229 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Implant Removed/Not Replaced | 4 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | V-loc and Monocryl |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 229 Participants |
| Age Continuous | 42.6 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Europe | 86 participants |
| Region of Enrollment United States | 143 participants |
| Sex: Female, Male Female | 213 Participants |
| Sex: Female, Male Male | 16 Participants |
| Surgical Procedure | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 72 / 229 | 44 / 229 | 19 / 229 | 84 / 229 |
| serious Total, serious adverse events | 4 / 229 | 1 / 229 | 0 / 229 | 11 / 229 |
Outcome results
Primary
Total Dermal Closure Time
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
Time frame: At time of surgery
Population: Includes only those subjects where a deep dermal layer was closed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V-Loc 180 / 90 Wound Closure Device | Total Dermal Closure Time | 12 Minutes | Standard Deviation 4.6 |
| 3-0 Monocryl Sutures | Total Dermal Closure Time | 19.2 Minutes | Standard Deviation 6.7 |
Secondary
Cosmesis
Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).
Time frame: 12 weeks
Population: Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| V-Loc 180 / 90 Wound Closure Device | Cosmesis | 13.7 units on a scale | Standard Deviation 2.8 |
| 3-0 Monocryl Sutures | Cosmesis | 13.6 units on a scale | Standard Deviation 3.1 |